22804 Federal Register / Vol. 76, No. 79 / Monday, April 25, 2011 / Rules and Regulations 

1The term ‘‘covered workers’’ refers to those 

individuals indentified in § 26.4(a) who are subject 

to the requirements in § 26.205. 

Paperwork Reduction Act 

This policy statement does not 

contain new or amended information 

collection requirements subject to the 

Paperwork Reduction Act of 1995 

(44 U.S.C. 3501 et seq.). Existing 

requirements were approved by the 

Office of Management and Budget 

(OMB), Approval Number 3150–0136. 

Public Protection Notification 

The NRC may not conduct or sponsor, 

and a person is not required to respond 

to, a request for information or an 

information collection requirement 

unless the requesting document 

displays a currently valid OMB control 

number. 

Congressional Review Act 

In accordance with the Congressional 

Review Act of 1996, the NRC has 

determined that this action is not a 

major rule and has verified this 

determination with the Office of 

Information and Regulatory Affairs, 

Office of Management and Budget. 

Accordingly, the NRC Enforcement 

Policy is revised to read as follows: 

NRC Enforcement Policy 

* * * * * 

9.2 Enforcement Discretion for the 

Minimum Days Off Requirements of 

§ 26.205(d)(3) 

This section sets forth the interim 

policy that the NRC will follow to 

exercise enforcement discretion for 

licensees who pursue the alternative 

approach to the minimum days off 

(MDO) requirements of § 26.205(d)(3). 

This alternative approach is consistent 

with the bases and objectives of 10 CFR 

part 26, specifically managing 

cumulative fatigue, and provides 

licensees improved simplicity and 

flexibility for work scheduling. 

This interim policy is only applicable 

to licensees who inform the NRC of 

their intent to adopt the alternative 

approach. Licensees shall comply with 

all requirements of Subpart I, as 

applicable, unless explicitly replaced or 

amended in this interim policy. The 

alternative approach to the MDO 

requirements applies to the work hours 

of covered individuals 1 during normal 

(e.g., non-outage/emergency) plant 

operations. This interim policy will 

remain in place until the 

implementation date of a revised final 

rule associated with the MDO 

requirements in 10 CFR part 26, subpart 

I. 

A licensee who informs the NRC of its 

intent to transition to the alternative 

approach will receive enforcement 

discretion, and no enforcement action 

will be taken for the violation of 

§ 26.205(d)(3). If at any time while the 

licensee is implementing this alternate 

approach it does not meet the 

requirements, as stated in this interim 

policy, the licensee may be in violation 

of § 26.205(d)(3) and subject to 

enforcement action. Once a licensee has 

transitioned to the alternate approach, it 

has the option to revert back to the 

requirement of § 26.205(d)(3); however, 

the licensee is only allowed one 

opportunity to do so. 

A. Actions and Requirements for 

Transition 

A licensee must inform the NRC of its 

intent to transition to the alternative 

approach. Notification shall be made via 

a letter to the respective Regional 

Administrator and shall identify the 

implementation date which will be set 

by the licensee. The hours worked prior 

to the implementation date, must meet 

the requirement of § 26.205(d)(3), or 

enforcement action may be taken. Once 

the NRC has been notified of the 

implementation date, the licensee can 

commence its transition to the alternate 

approach. 

In order to receive continuous 

enforcement discretion once the 

alternate approach is implemented, each 

covered worker is limited to a weekly 

average of 54 hours worked, calculated 

using a rolling window of up to 6 

weeks. This alternative is not applicable 

to unit outages or security system 

outages. Any instance of an individual’s 

average weekly work hours exceeding 

the requirements for enforcement 

discretion may result in a violation of 

the MDO requirements. Typically, an 

instance of an isolated occurrence or 

occurrences with limited duration 

would generally be considered either a 

minor violation or a non-cited violation. 

B. Required Actions for Transition Back 

to the MDO Requirement 

At any time prior to the 

implementation date of a revised final 

rule associated with the MDO 

requirements in 10 CFR part 26, subpart 

I, ‘‘Managing Fatigue,’’ the licensee has 

the option to transition back to the MDO 

requirements. However, the licensee has 

this option only once. The licensee must 

submit a written notification to the 

respective Regional Administrator 

stating that it is reverting back to 

compliance with the MDO requirements 

as specified under § 26.205(d)(3), and 

shall give the NRC advance notice of its 

transition date. There will be no 

enforcement action taken on any MDO 

violations that occurred while the 

licensee was implementing the alternate 

approach, unless the licensee failed to 

meet the requirements as stated in 

Section 9.2.A of this policy. 

Dated at Rockville, Maryland, this 19th day 

of April 2011. 

For the Nuclear Regulatory Commission. 

Annette L. Vietti-Cook, 

Secretary of the Commission. 

[FR Doc. 2011–9916 Filed 4–22–11; 8:45 am] 

BILLING CODE 7590–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

19 CFR part 101 

[CBP Dec. 11–08] 

Technical Amendment to List of CBP 

Preclearance Offices in Foreign 

Countries: Addition of Dublin, Ireland 

AGENCY: U.S. Customs and Border 

Protection, DHS. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: This document amends U.S. 

Customs and Border Protection (CBP) 

regulations to reflect that U.S. Customs 

and Border Protection (CBP) has added 

a preclearance station in Dublin, 

Ireland. CBP officers at preclearance 

stations conduct inspections and 

examinations to ensure compliance with 

U.S. customs, immigration, and 

agriculture laws, as well as other laws 

enforced by CBP at the U.S. border. 

Such inspections and examinations 

prior to arrival in the United States 

generally enable travelers to exit the 

domestic terminal or connect directly to 

a U.S. domestic flight without 

undergoing further CBP processing. 

DATES: Effective Date: April 25, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Kathleen Conway, Office of Field 

Operations, Preclearance Operations, 

(202) 344–1759. 

SUPPLEMENTARY INFORMATION: 

Background 

CBP preclearance operations have 

been in existence since 1952. 

Preclearance facilities are established 

through the cooperative efforts of CBP, 

foreign government representatives, and 

the local facility authorities and are 

evidenced with signed preclearance 

agreements. Each facility is staffed with 

CBP officers responsible for conducting 


jdjones on DSKHWCL6B1PROD with RULES
Federal Register / Vol. 76, No. 79 / Monday, April 25, 2011 / Rules and Regulations 22805 

inspections and examinations in 

connection with preclearing passengers, 

crew, and their goods bound for the 

United States. Generally, travelers who 

are inspected at a preclearance facility 

are permitted to arrive at a U.S. 

domestic facility and exit the U.S. 

domestic terminal upon arrival or 

connect directly to a U.S. domestic 

flight without further CBP processing. 

Preclearance facilities primarily serve to 

facilitate low risk travelers, relieve 

passenger congestion at federal 

inspection facilities in the United 

States, and enhance security in the air 

environment through the screening and 

inspection of travelers prior to their 

arrival in the United States. In Fiscal 

Year 2010, over 14 million aircraft 

travelers were processed at preclearance 

locations. This figure represents more 

than 16 percent of all commercial 

aircraft travelers cleared by CBP in FY 

2010. 

The Agreement Between the 

Government of the United States of 

America and the Government of Ireland 

on Air Transport Preclearance was 

signed on November 17, 2008. 

Preclearance operations began in 

Dublin, Ireland on January 19, 2011. 

The Dublin preclearance station is open 

for use by commercial flights. 

Section 101.5 of the CBP regulations 

(19 CFR 101.5) sets forth a list of CBP 

preclearance offices in foreign countries. 

This document amends this section to 

add Dublin, Ireland to the list of 

preclearance offices. 

Inapplicability of Public Notice and 

Delayed Effective Date Requirements 

This amendment reflects the addition 

of a new CBP preclearance office that 

was established through a signed 

agreement between the United States 

and the Government of Ireland. 

Accordingly, pursuant to 5 U.S.C. 

553(b)(B), notice and public procedure 

are unnecessary. For the same reason, 

pursuant to 5 U.S.C. 553(d)(3), a delayed 

effective date is not required. 

The Regulatory Flexibility Act and 

Executive Order 12866 

Because no notice of proposed 

rulemaking is required, the provisions 

of the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.) do not apply. This 

amendment does not meet the criteria 

for a ‘‘significant regulatory action’’ as 

specified in Executive Order 12866. 

Signing Authority 

This document is being issued in 

accordance with 19 CFR 0.2(a). 

List of Subjects in 19 CFR Part 101 

Customs duties and inspection, 

Customs ports of entry, Foreign trade 

statistics, Imports, Organization and 

functions (Government agencies), 

Shipments, Vessels. 

Amendments to Regulations 

For the reasons set forth above, Part 

101 of the Code of Federal Regulations 

(19 CFR part 101), is amended as set 

forth below. 

PART 101—GENERAL PROVISIONS 

■ 1. The general authority citation for 

part 101 and the specific authority 

citation for section 101.5 continue to 

read as follows: 

Authority: 5 U.S.C. 301; 19 U.S.C. 2, 66, 

1202 (General Note 3(i), Harmonized Tariff 

Schedule of the United States), 1623, 1624, 

1646a. 

* * * * * 

Section 101.5 also issued under 19 U.S.C. 

1629. 

* * * * * 

■ 2. Revise § 101.5 to read as follows: 

§ 101.5 CBP preclearance offices in 

foreign countries. 

Listed below are the preclearance 

offices in foreign countries where CBP 

officers are located. A Director, 

Preclearance, located in the Office of 

Field Operations at CBP Headquarters, 

is the responsible CBP officer exercising 

supervisory control over all 

preclearance offices. 

Country CBP office 

Aruba ............ Orangestad. 

The Bahamas Freeport. 

Nassau. 

Bermuda ....... Kindley Field. 

Canada ......... Calgary, Alberta. 

Edmonton, Alberta. 

Halifax, Nova Scotia. 

Montreal, Quebec. 

Ottawa, Ontario. 

Toronto, Ontario. 

Vancouver, British Columbia. 

Winnipeg, Manitoba. 

Ireland .......... Dublin. 

Shannon. 

Dated: February 11, 2011. 

Alan D. Bersin, 

Commissioner, U.S. Customs and Border 

Protection. 

[FR Doc. 2011–9883 Filed 4–22–11; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 878 

[Docket No. FDA–2006–N–0045] (Formerly 

Docket No. 2006N–0109) 

Medical Devices; Reclassification of 

the Topical Oxygen Chamber for 

Extremities 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is reclassifying 

the topical oxygen chamber for 

extremities (TOCE) from class III to class 

II. This device is intended to surround 

a patient’s limb and apply humidified 

oxygen topically at a pressure slightly 

greater than atmospheric pressure to aid 

healing of chronic skin ulcers, such as 

bedsores. This reclassification is on the 

Secretary of Health and Human 

Services’s own initiative based on new 

information. This action is being taken 

under the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) as 

amended by the Medical Device 

Amendments of 1976 (the 1976 

Amendments), the Safe Medical Devices 

Act of 1990 (the SMDA), and the Food 

and Drug Administration Modernization 

Act of 1997 (FDAMA). Elsewhere in this 

issue of the Federal Register, FDA is 

announcing the availability of the 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document: 

Topical Oxygen Chamber for 

Extremities,’’ which will serve as the 

special control for this device. 

DATES: This rule is effective May 25, 

2011. 

FOR FURTHER INFORMATION CONTACT: 

Charles N. Durfor, Center for Devices 

and Radiological Health (HFZ–410), 

Food and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

240–276–3555. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The FD&C Act (21 U.S.C. 301 et seq.), 

as amended by the 1976 Amendments 

(Pub. L. 94–295), the SMDA (Pub. L. 

101–629), and the FDAMA (Pub. L. 105– 

115), established a comprehensive 

system for the regulation of medical 

devices intended for human use. 

Section 513 of the FD&C Act (21 U.S.C. 

360c) established three categories 

(classes) of devices, depending on the 

regulatory controls needed to provide 

reasonable assurance of their safety and 


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